Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy

NCT03033719 | Unknown

• 2 other identifiers: K1309012016-A00312-49
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the postoperative global morbidity between patients who have been operated on for a colon cancer by laparotomy and those operated on by laparoscopy

Conditions

Colonic Cancer

Keywords

Colorectal Surgery; Geriatrics; Digestive Oncology; Colon cancer; Elderly patients; Laparoscopy; Laparotomy; Morbidity

Outcome Measures

Primary Outcomes (1)

• Global postoperative morbidity in both arms

  Postoperative morbidity is defined as any surgical or medical complications occurring up to 30 days after surgery. It will be collected using a standardized collection form during hospitalization and eventual subsequent consultations in case of patient discharge before then

  At 30 days after the surgery

Secondary Outcomes (11)

• Postoperative mortality

  Evaluated at 30 days and at 90 days after the surgery

• Rate of readmission

  Within the 30 days after discharge of the patient

• Number of examined lymph nodes

  At surgery

• Type of resection (R0 or R1)

  At surgery

• Pathological evaluation of mesocolic resection quality

  At surgery

Other Outcomes (4)

• To establish a specific molecular classification of colon cancer in the elderly from expression chips

  within the 15 years after the tumor sampling

• To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations

  within the 15 years after the tumor sampling

• To establish a possible link between these molecular subtypes and overall survival of patients

  within the 15 years after the tumor sampling

Study Arms (2)

Laparotomy

ACTIVE COMPARATOR

Open surgery

Procedure: Laparotomy

Laparoscopy

EXPERIMENTAL

Minimally invasive surgery

Procedure: Laparoscopy

Interventions

Laparotomy PROCEDURE

Open surgery

Also known as: Open surgery

Laparotomy

Laparoscopy PROCEDURE

Minimally invasive surgery

Also known as: Minimally invasive surgery

Laparoscopy

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 75 years
• Histologically proven colonic adenocarcinoma (\> 15 cm from the anal margin) or precancerous colonic lesion non endoscopically resectable
• Uncomplicated colonic tumor (no preoperative suspicion of invasion of adjacent structures as assessed by CT-scan (cT4), no tumoral perforation, or tumoral obstruction, or abscess, or hemorrhage)
• No previous colonic cancer within the 5 last years
• No peritoneal carcinosis on CT-scan
• Patient able to fill in an auto-questionnaire alone or with some help
• MMS (Mini Mental Score) ≥ 15
• Given oral consent (formal informed consent is not required by French law for accepted procedures)

You may not qualify if:

• Rectal cancer (≤ 15 cm from the anal margin)
• Locally advanced (cT4) or complicated tumor requiring extended resection or emergency surgery
• Synchronous colonic cancer
• \- Scheduled need for synchronous intra-abdominal surgery, including surgery for liver metastases
• Absolute contraindications to general anesthesia or prolonged pneumoperitoneum
• Patient not able to tolerate colon surgery according to the global comprehensive geriatric assessment
• Estimated life expectancy less than 6 months
• Patient under guardianship
• Other known active cancer (except nonmelanomatous skin cancer)
• Patient not affiliated to the social security system
• Previous colonic resection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Related Publications (1)

• Manceau G, Brouquet A, Chaibi P, Passot G, Bouche O, Mathonnet M, Regimbeau JM, Lo Dico R, Lefevre JH, Peschaud F, Facy O, Volpin E, Chouillard E, Beyert-Berjot L, Verny M, Karoui M, Benoist S. Multicenter phase III randomized trial comparing laparoscopy and laparotomy for colon cancer surgery in patients older than 75 years: the CELL study, a Federation de Recherche en Chirurgie (FRENCH) trial. BMC Cancer. 2019 Dec 4;19(1):1185. doi: 10.1186/s12885-019-6376-8.

  PMID: 31801485 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Laparotomy; Conversion to Open Surgery; Laparoscopy; Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gilles MANCEAU, M.D., PhD.,

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles MANCEAU, M.D., PhD.,

CONTACT

00331 42 17 56 51; gilles.manceau@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 27, 2017
• Study Start: July 4, 2017
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 12, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)